A Prospective, Randomized, Single-blind, Self-controlled Study Evaluating the Efficacy of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) Combined With Stapokibart in the Treatment of Type 2 Chronic Rhinosinusitis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Visual analogue scale(VAS) score of nasal symptoms
研究概览
简要总结
Through a prospective study, the efficacy of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) in the surgical treatment of patients with type 2 chronic rhinosinusitis was verified. The aim was to provide evidence-based medical evidence for the effectiveness of local minimally invasive surgery combined with biologics in the treatment of type 2 chronic rhinosinusitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic criteria for chronic rhinosinusitis refer to "Chinese Guidelines for Diagnosis and Treatment of Chronic Rhinosinusitis (2024)", namely: (1) Symptoms: nasal congestion, nasal discharge; secondary symptoms: headache in the head and face, reduced or lost sense of smell. (2) Endoscopic examination: bilateral lesions, mucous or mucopurulent secretions from the middle meatus and choana, nasal mucosa congestion, edema or polyps. The difference in endoscopic scores between both sides is no more than
- •(3) Imaging examination: bilateral lesions, nasal sinus CT scan can show the ostiomeatal complex and/or inflammatory lesions of the nasal sinus mucosa. The difference in CT scores between both sides is no more than
- •Diagnostic criteria for type 2 chronic rhinosinusitis refer to "2023 EPOS on the indications for biological therapy of CRSwNP", namely: (1) Evidence of type 2 inflammation: eosinophils (EOS) >=10/hpf in tissue, or EOS>=150 in blood, or total IgE >=100; (2) Need for systemic glucocorticoids or contraindications to systemic glucocorticoids: >= 2 courses per year, or long-term (> 3 months) low-dose glucocorticoids; (3) Significant impairment of quality of life: SNOT-22 >= 40; (4) Obvious loss of sense of smell: loss of sense of smell in the smell test; (5) Diagnosis of combined asthma: asthma requiring regular inhalation of glucocorticoids. Three of the five conditions can diagnose type 2 inflammation.
- •History of rhinosinusitis for more than 2 years, patients enrolled in China-Japan Union Hospital of Jilin University whose residence is in Northeast China meet the requirements for postoperative follow-up (including Heilongjiang Province, Jilin Province, Liaoning Province, and Hulunbuir City, Xing'an League, Tongliao City, Chifeng City, and Xilingol League of Inner Mongolia Autonomous Region). Patients enrolled in the First Affiliated Hospital of Jinan University whose residence is in southern China meet the requirements for postoperative follow-up (including Guangdong Province and Guangxi Zhuang Autonomous Region).
排除标准
- •Pregnant women.
- •Patients with diabetes, hypertension, coronary heart disease, tuberculosis, asthma, and malignant tumors who cannot tolerate general anesthesia surgery.
- •Other patients who are unable to receive or unwilling to undergo surgical treatment due to severe systemic diseases or mental disorders.
- •Patients who are unable to cooperate with postoperative follow-up.
- •Age < 18 years old or > 75 years old.
- •Patients who have received allergen-specific immunotherapy or biological agent treatment within the past year.
- •Patients with a history of sinus surgery in the past.
- •Those with acute infectious diseases, upper respiratory tract infections or systemic inflammatory symptoms such as fever and chills.
- •Those who cannot tolerate severe systemic or local adverse reactions during relevant examinations or specimen collection.
- •Patients whom the researchers consider ineligible for enrollment.
结局指标
主要结局
Visual analogue scale(VAS) score of nasal symptoms
时间窗: Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
The minimum possible scale value is 0, and the maximum possible scale value is 10. The higher scores mean a worse outcome.
Nasal endoscopy score(Lund-Kennedy scores, LKs)
时间窗: Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
The minimum possible scale value is 0, and the maximum possible scale value is 10. The higher scores mean a worse outcome.
Paranasal sinus CT score(Lund-Mackey scores, LMs)
时间窗: 6 months and 12 months after surgery.
The minimum possible scale value is 0, and the maximum possible scale value is 12. The higher scores mean a worse outcome.
Nasal polyps scores(NPs)
时间窗: Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
The minimum possible scale value is 0, and the maximum possible scale value is 4. The higher scores mean a worse outcome.
Questionnaire score for Sinusitis Quality of Life(SNOT-22 scores)
时间窗: Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
The minimum possible scale value is 0, and the maximum possible scale value is 110. The higher scores mean a worse outcome.
Visual analogue scale(VAS) score of nasal symptoms
时间窗: Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
The minimum possible scale value is 0, and the maximum possible scale value is 10. The higher scores mean a worse outcome.
Nasal endoscopy score(Lund-Kennedy scores, LKs)
时间窗: Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
The minimum possible scale value is 0, and the maximum possible scale value is 10. The higher scores mean a worse outcome.
Paranasal sinus CT score(Lund-Mackey scores, LMs)
时间窗: 6 months and 12 months after surgery.
The minimum possible scale value is 0, and the maximum possible scale value is 12. The higher scores mean a worse outcome.
Nasal polyps scores(NPs)
时间窗: Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
The minimum possible scale value is 0, and the maximum possible scale value is 4. The higher scores mean a worse outcome.
Questionnaire score for Sinusitis Quality of Life(SNOT-22 scores)
时间窗: Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
The minimum possible scale value is 0, and the maximum possible scale value is 110. The higher scores mean a worse outcome.
次要结局
- Life quality score(SF-36 scores)(Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.)
- Life quality score(SF-36 scores)(Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.)
研究者
Dongdong Zhu
Department Director
China-Japan Union Hospital